01 1ALLEGRANZI MIKRONEVE S.A.S. DI ALLEGRANZI S.R.L. Cordignano IT
02 1IMERYS CARBONATES AUSTRIA GMBH Ebensee AT
03 1IMERYS CARBONATES USA INC. Roswell US
04 1J.M. HUBER MICROPOWDERS, INC. Atlanta US
05 1MINERARIA SACILESE S.P.A. Sacile IT
06 1Merck KGaA Darmstadt DE
07 1OMYA SAS Omey FR
08 2SUDEEP PHARMA PRIVATE LIMITED Vadodara IN
09 1Scora SA Caffiers FR
10 1Shanghai NuoCheng Pharmaceutical Co., Ltd. Shanghai CN
11 1Società Generale per l'Industria della Magnesia S.p.A. Angera (Va) IT
12 1Specialty Minerals Lifford Birmingham GB
01 10Calcium carbonate
02 1Calcium carbonate, Granular
03 1Calcium carbonate, Micronised 30
04 1Calcium carbonate, Sieved grade I (35), sieved grade II (65)
01 1China
02 4France
03 1Germany
04 2India
05 2Italy
06 2U.S.A
07 1Blank
01 12Valid
02 1Withdrawn by Holder
Certificate Number : R1-CEP 1996-025 - Rev 02
Status : Valid
Issue Date : 2006-06-23
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 2003-019 - Rev 03
Status : Valid
Issue Date : 2018-03-02
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 2004-091 - Rev 02
Status : Valid
Issue Date : 2021-09-16
Type : Chemical
Substance Number : 14
Calcium Carbonate, Micronised 30
Certificate Number : CEP 2016-258 - Rev 01
Status : Valid
Issue Date : 2024-10-04
Type : Chemical
Substance Number : 14
Calcium Carbonate, Sieved Grade I (35), Sieved G...
Certificate Number : R1-CEP 2001-366 - Rev 04
Status : Valid
Issue Date : 2021-05-25
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 1997-065 - Rev 04
Status : Valid
Issue Date : 2008-09-16
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 2007-132 - Rev 01
Status : Valid
Issue Date : 2022-02-10
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 2003-242 - Rev 00
Status : Valid
Issue Date : 2009-07-20
Type : Chemical
Substance Number : 14
Certificate Number : R1-CEP 2013-299 - Rev 02
Status : Valid
Issue Date : 2022-08-31
Type : Chemical
Substance Number : 14
Certificate Number : R0-CEP 2020-379 - Rev 01
Status : Valid
Issue Date : 2022-09-02
Type : Chemical
Substance Number : 14
A Calcium Carbonate manufacturer is defined as any person or entity involved in the manufacture, preparation, processing, compounding or propagation of Calcium Carbonate, including repackagers and relabelers. The FDA regulates Calcium Carbonate manufacturers to ensure that their products comply with relevant laws and regulations and are safe and effective to use. Calcium Carbonate API Manufacturers are required to adhere to Good Manufacturing Practices (GMP) to ensure that their products are consistently manufactured to meet established quality criteria.
click here to find a list of Calcium Carbonate manufacturers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PhamaCompass.
A Calcium Carbonate supplier is an individual or a company that provides Calcium Carbonate active pharmaceutical ingredient (API) or Calcium Carbonate finished formulations upon request. The Calcium Carbonate suppliers may include Calcium Carbonate API manufacturers, exporters, distributors and traders.
click here to find a list of Calcium Carbonate suppliers with USDMF, JDMF, KDMF, CEP, GMP, COA and API Price related information on PharmaCompass.
A Calcium Carbonate CEP of the European Pharmacopoeia monograph is often referred to as a Calcium Carbonate Certificate of Suitability (COS). The purpose of a Calcium Carbonate CEP is to show that the European Pharmacopoeia monograph adequately controls the purity of Calcium Carbonate EP produced by a given manufacturer. Suppliers of raw materials can prove the suitability of Calcium Carbonate to their clients by showing that a Calcium Carbonate CEP has been issued for it. The manufacturer submits a Calcium Carbonate CEP (COS) as part of the market authorization procedure, and it takes on the role of a Calcium Carbonate CEP holder for the record. Additionally, the data presented in the Calcium Carbonate CEP (COS) is managed confidentially and offers a centralized system acknowledged by numerous nations, exactly like the Calcium Carbonate DMF.
A Calcium Carbonate CEP (COS) is recognised by all 36 nations that make up the European Pharmacopoeia Convention. Calcium Carbonate CEPs may be accepted in nations that are not members of the Ph. Eur. at the discretion of the authorities there.
click here to find a list of Calcium Carbonate suppliers with CEP (COS) on PharmaCompass.
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